kinderBAND

Primary DI
00863457000302
Brand
kinderBAND
Company
BIOSCULPTOR CORPORATION
Model
CL-4000
Catalog number
CL-4000
Device description
The kinderBAND™ cranial remolding orthosis is a custom made orthotic device available by prescription only. It is used to treat infants between 3 and 18 months of age for asymmetrical head shapes such as positional plagiocephaly, brachycephaly and scaphocephaly.
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVAOrthosis, Cranial
OANOrthosis, Cranial, Laser Scan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVAOrthosis, CranialNeurology2
OANOrthosis, Cranial, Laser ScanNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081787000CAMLAB CRANIAL ORTHOSIS HELMETBiosculptor Corporation2009-01-27OAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863457000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863457000302008634570003028634570003020863457000302

GMDN Terms#

Term, Definition table
TermDefinition
Cranial orthosisA custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-246-2884info@kinderband.net

Regulatory Flags#

DUNS number
926813379
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050250771Maramed Orthopedic SystemsPLS-FF-100LPLS-FF-100L2023-11-29
00810050250788Maramed Orthopedic SystemsPLS-FF-100RPLS-FF-100R2023-11-29
00810050250795Maramed Orthopedic SystemsPLS-FF-200LPLS-FF-200L2023-11-29
00810050250801Maramed Orthopedic SystemsPLS-FF-200RPLS-FF-200R2023-11-29
00810050250818Maramed Orthopedic SystemsPLS-FF-300LPLS-FF-300L2023-11-29
00810050250825Maramed Orthopedic SystemsPLS-FF-300RPLS-FF-300R2023-11-29
00810050250832Maramed Orthopedic SystemsPLS-FF-400LPLS-FF-400L2023-11-29
00810050250849Maramed Orthopedic SystemsPLS-FF-400RPLS-FF-400R2023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859065006041Hanger Cranial BandSymbiont Logistics, LLCMVA2026-05-11
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00860013898090Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
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00860015811103TaleeINVENT MEDICAL USA LLCMVA2026-04-28
00860015811103TaleeINVENT MEDICAL USA LLCOAN2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCOAN2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCMVA2026-04-28
00860013026103Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013026103Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.MVA2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.OAN2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898007TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCMVA2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCOAN2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCOAN2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCMVA2025-05-12
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